Statement of the Advanced Medical Technology Association (AdvaMed)

AdvaMed, the Advanced Medical Technology Association, is pleased to submit this comment for the record on the important role that disease management can play in the delivery of high quality, cost effective medical care to the growing number of seniors and people with disabilities under Medicare.

AdvaMed is the world’s largest association of medical technology manufacturers, with over 1,100 members worldwide.  Our members develop and produce the advanced medical technologies that are integral to disease management and other innovation forms of high quality health care delivery.

Disease management technologies have a key role to play in Medicare in the 21^st century:  improving patient care, improving health system efficiency, and reducing overall costs.  Realizing these benefits will be critical in the coming years as Medicare faces a rapid increase in the number of beneficiaries it serves.  AdvaMed supports efforts by Congress and the Centers for Medicare and Medicaid Services (CMS) to expand access to technologies that facilitate the management of disease – by ensuring adequate reimbursement and coverage.

AdvaMed believes the following three key points are important to keep in mind when considering the increasingly important role of disease management technologies:

(1) The aging population of the U.S. demands technology solutions to manage chronic disease and reduce disability.

(2) Technologies will likely bring the greatest strides in the future towards improving the management of chronic and short-term diseases.

(3) Medicare should take steps to encourage more timely adoption of medical technologies that facilitate disease management.

The aging population of the U.S. demands technology solutions to manage chronic disease and reduce disability.

The United States faces unprecedented challenges in the number of elderly patients who will rely on Medicare to ensure their health and well-being.  Based on historic trends, the most expensive patients are those that need ongoing institutional care—and the costs of caring for patients in nursing homes accounts for a growing share of our health care budgets.  Other expensive critical care services also are expected to become more numerous as the elderly population grows.

Fortunately, technologies offer the potential for many to change the paradigm of care and reduce hospitalizations and allow patients with serious chronic conditions to lead active, productive, independent lives.  Recent advances offer cost-effective solutions to some of the conditions that are the costliest to Medicare, such as congestive heart failure, diabetes, and coronary artery disease.

Study results announced in March at the 2002 American College of Cardiology Annual Scientific Session show one way that advanced medical technology can improve health care quality and efficiency.  The study found that a breakthrough technology called cardiac resynchronization therapy can reduce by 50% the number of hospitalizations for congestive heart failure.  Heart rhythm disorders currently account for more than 761,000 hospital visits annually at a cost of more than $6,000 apiece.

Drug-eluting stents (stents that slowly release medication after being implanted to keep the coronary artery open) show promise in eliminating the problem of arteries renarrowing, or restenosis – which is a major cause of repeat medical procedures in patients with coronary artery disease.  In recent clinical trials, drug-eluting stents completed eliminated restenosis.  This "could become one of the biggest breakthroughs in treating cardiovascular disease," according to the American Heart Association.

A landmark study published last year by Duke University researcher Kenneth Manton, PhD illustrates one way that innovative tests and treatments are reducing the number of people who need disease management and yielding long-term savings.  Manton’s research finds that, due in part to advances in medical technology, the rate of chronic disability among Medicare-age patients has fallen significantly over the last two decades.  In fact, today there are 1.4 million fewer Medicare beneficiaries with chronic disability than would have been the case without these gains.  This reduction saved Medicare an estimated $19 billion in 1999.

Technologies will enable the greatest strides in the future towards improving the management of chronic and short term diseases.

Medical technology innovations are helping make effective disease and case management a reality.  Many emerging breakthroughs are empowering patients to take a more active role in the effective management of their disease or condition.

Recently FDA approved the first-ever cardiac pacemakers with remote monitoring capability.  This technology enables patients to transmit information about their heart condition and pacemaker performance from home directly to their caregiver.  These "virtual office visits" promise to improve patient care and increase efficiency in treating patients with chronic heart conditions through more timely follow-up and better overall patient management.

Advances in diabetes detection and monitoring are playing key roles in the management of the disease.  Diabetes and its related complications consume one of every four Medicare dollars.  The Centers for Disease Control and Prevention (CDC) warns it is “a major public health threat of epidemic proportions."

Recently, the first-ever non-invasive blood glucose monitor became available in the U.S.  HHS Secretary Tommy Thompson remarked that introduction of the device "heralds the advent of new technologies that promise dramatic improvements in the quality of life for the millions of Americans who have diabetes."

In 2001, new technologies also were introduced to make blood glucose monitoring simpler and less painful.  One product made available last year was the world's first combined blood glucose monitoring and insulin dosing system.  In addition, a growing number of monitors were introduced that allow patients to draw blood samples from sites other than the fingertip, such as the arm.  HHS Secretary Thompson also recently called on doctors to test many people for "pre-diabetes," a condition of elevated blood glucose levels that often leads to diabetes.

Advanced diagnostic technology called prothrombin self-testing allows patients on blood-thinning drugs like Coumadin to closely monitor their clotting time (prothrombin time) at home. Information from the test enables the physician to adjust the blood-thinning medication to avoid serious complications like bleeding and stroke.

The genomics revolution also is yielding gains in disease management.  New genomic disease management tests, by providing new information not currently available through existing methods, enable physicians to diagnose disease more quickly and accurately, to determine the most appropriate treatment and to monitor disease progression and reoccurrence during therapy. These tests also enable the detection of disease at the very early or developing stages when treatment is likely to be most effective.

In addition, many new information management technologies are emerging to help providers successfully monitor and care for patients across the spectrum of the health care delivery system.

Medicare should take steps to encourage more timely adoption of medical technologies that facilitate disease management.

Unfortunately, Medicare procedures and policies often discourage the adoption of new medical technologies that can facilitate disease management – or reduce the need for it altogether.

Diabetes testing policy:

CMS has issued several policies to reduce reimbursement and restrict access to the glucose monitoring technologies patients need to achieve tight glucose control.  Congress and CMS must work to remove these restrictive policies and ensure that Medicare patients have access to advanced monitoring technology.

Recently CMS finalized a policy to cut reimbursement for blood glucose testing by 26%.  The Congressional Diabetes Caucus had expressed concern to CMS that it was employing a flawed process to make this cut.

In early 2000, CMS issued an extremely burdensome policy that is discouraging close monitoring of glucose levels for patients in nursing homes.  Despite the fact that glucose monitoring is designed to show a trend in glucose levels over time, CMS has said that nursing home caregivers must obtain a physician's order for each individual measurement that is taken.  Because it is impractical and time consuming to obtain a physician's order for each measurement, this requirement has meant that nursing homes must either perform fewer glucose tests or absorb the cost of perform needed tests.

CMS further restricted Medicare patients' access to glucose testing in a recent policy that allows them to purchase glucose monitors and test strips only from retailers that are Medicare suppliers.  However, because of Medicare's burdensome and complex requirements for gaining recognition as a Medicare supplier, many small retailers choose not to apply for this status.  This policy, which has never been applied to any other product or service under Medicare, could make it difficult for many patients to purchase the glucose monitors and supplies they need, especially in rural areas that lack a Medicare supplier.

Innovative diagnostic tests:

In addition to problems specific to diabetes tests, other diagnostic tests integral to successful disease management face significant barriers at Medicare.

A report issued by the Institute of Medicine (IoM) on Medicare policy and procedures for diagnostic tests states that "current Medicare payment policy for outpatient clinical laboratory services seems not only outdated, but also irrational.”  The report concluded that "Medicare needs a more timely and appropriate method for integrating the proliferation of new technologies anticipated in the near future.”

Legislation pending in the Senate and passed by the House as part of the Medicare Regulatory Relief bill (H.R. 3391) would help address the serious problems in Medicare's procedures for new diagnostic tests.  It would establish an open public process for gathering input on reimbursement decisions for new tests and require Medicare to establish objective criteria for setting payment rates.

Hospital inpatient coding and payment:

CMS typically takes two years or more to fully integrate new medical technologies like coronary stents into the hospital inpatient payment program.  A regulation published by the agency last year on adoption of new medical technologies into the inpatient setting leaves in place current delays in Medicare coding and payment decisions that create barriers to patient access to medical technologies.

Congress and CMS must take steps to support patient access by eliminating delays in assignment of new codes and adequate payment rates for new inpatient technologies.  H.R. 2973, bipartisan legislation introduced in the House by Reps. Jim Ramstad (R-MN) and Karen Thurman (D-FL), would take steps to improve patient access to innovative technologies in the inpatient hospital setting.

Medicare technology adoption delays:

According to a report by the Lewin Group, Medicare can take 15 months to five years or more to integrate new medical technologies into the program.  This has a significant impact on patient and provider access to innovative disease management technologies like remote monitoring devices, gene-based testing and diabetes monitoring.

H.R. 3391 contains provisions from H.R. 2973 to improve accountability and coordination between offices in CMS that make coverage, coding and payment decisions on new technologies.

Healthcare information technology:

In its report Crossing the Quality Chasm, the IoM said “health care delivery has been relatively untouched by the revolution in information technology that has been transforming nearly every other aspect of society.”  Many of these information technologies play a key role is successful disease management. Medicare must ensure that health care providers have the resources they need to adopt effective new information technologies.

AdvaMed appreciates the Subcommittee’s interest in technologies that facilitate disease management and other innovative forms of high quality health care delivery.  Given the vital role disease management technologies play in improving patient care, spurring health system efficiency, and reducing overall costs, AdvaMed and its member companies look forward to the opportunity to work with the Subcommittee on these issues in the future.